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Safety and immunoge...
Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults : A phase II, randomized, controlled study
- Article/chapterEnglish2014
Publisher, publication year, extent ...
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Elsevier BV,2014
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printrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:uu-224365
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-224365URI
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https://doi.org/10.1016/j.vaccine.2014.01.019DOI
Supplementary language notes
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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Background: This study investigated the safety and immunogenicity of different formulations and schedules of a candidate subunit herpes zoster vaccine containing varicella-zoster virus glycoprotein E (gE) with or without the adjuvant system ASO1(B). Methods: In this phase II, single-blind, randomized, controlled study, adults aged >= 60 years (N = 714) received one dose of 100 mu g gE/AS01(B), two doses, two months apart, of 25, 50, or 100 mu g gE/AS01(B), or two doses of unadjuvanted 100 mu g gE/saline. Frequencies of CD4(+) T cells expressing >= 2 activation markers following induction with gE were measured by intracellular cytokine staining and serum anti-gE antibody concentrations by ELISA. Results: Frequencies of gE-specific CD4(+) T cells were >3-fold higher after two doses of all gE/AS01(B) formulations than after one dose of 100 mu g gE/AS01(B) or two doses of 100 mu g gE/saline. Frequencies were comparable after two doses of 25, 50, or 100 mu g gE/AS01g. Serum anti-gE antibody concentrations were comparable after two doses of 50 or 100 mu g gE/AS01(B) and higher than in the other groups. Immune responses persisted for at least 36 months. Reactogenicities of all gE/AS01(B) formulations were similar but greater than with gE/saline. Conclusions: The three formulations of gE/AS01(B) were immunogenic and well tolerated in adults aged >= 60 years. Two vaccinations with gE/AS01(B) induced higher immune responses than one and the dose of gE impacted humoral but not cellular immune responses (NCT00434577).
Subject headings and genre
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Varicella-zoster virus
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Herpes zoster
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Vaccine
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Adjuvant
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gE
Added entries (persons, corporate bodies, meetings, titles ...)
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Smetana, Jan
(author)
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Pauksens, KarlisUppsala universitet,Infektionssjukdomar(Swepub:uu)karlpauk
(author)
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Rombo, Lars
(author)
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Van den Hoek, J. Anneke R.
(author)
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Richardus, Jan H.
(author)
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Plassmann, Georg
(author)
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Schwarz, Tino F.
(author)
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Ledent, Edouard
(author)
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Heineman, Thomas C.
(author)
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Uppsala universitetInfektionssjukdomar
(creator_code:org_t)
Related titles
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In:Vaccine: Elsevier BV32:15, s. 1745-17530264-410X1873-2518
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Chlibek, Roman
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Smetana, Jan
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Pauksens, Karlis
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Rombo, Lars
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Van den Hoek, J. ...
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Richardus, Jan H ...
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Plassmann, Georg
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Schwarz, Tino F.
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Ledent, Edouard
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Vaccine
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Uppsala University